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EMA Updates Nitrosamine Q&A Guidance: New Requirements for Acceptable Intake Limits and Less-Than-Lifetime Exposure
The European Medicines Agency (EMA) has revised its Questions and Answers guidance for marketing authorisation holders (MAHs) and applicants on nitrosamine impurities in human medicinal products. Revision 24, dated 3 November 2026, introduces important clarifications on acceptable intake (AI) limits, less-than-lifetime (LTL) exposure, other N-nitroso compounds and nitrosamines originating from excipients. The update also revises existing recommendations on risk factors, contr

Sharan Murugan
45 minutes ago3 min read
